lotrimin ultra

Generic: butenafine hydrochloride

Labeler: bayer healthcare llc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lotrimin ultra
Generic Name butenafine hydrochloride
Labeler bayer healthcare llc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

butenafine hydrochloride 1 g/100g

Manufacturer
Bayer Healthcare LLC.

Identifiers & Regulatory

Product NDC 11523-0082
Product ID 11523-0082_4526ca36-993f-b574-e063-6294a90a8fba
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021307
Listing Expiration 2026-12-31
Marketing Start 2021-12-20

Pharmacologic Class

Classes
benzylamine antifungal [epc] benzylamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115230082
Hyphenated Format 11523-0082

Supplemental Identifiers

RxCUI
1298448
UPC
0000000000000
UNII
R8XA2029ZI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lotrimin ultra (source: ndc)
Generic Name butenafine hydrochloride (source: ndc)
Application Number NDA021307 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

11523-0082-1 1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

butenafine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Lotrimin Ultra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4526ca36-993f-b574-e063-6294a90a8fba", "openfda": {"upc": ["0000000000000"], "unii": ["R8XA2029ZI"], "rxcui": ["1298448"], "spl_set_id": ["d11dfdf6-9b36-03bc-e053-2995a90a0bc3"], "manufacturer_name": ["Bayer Healthcare LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1)  / 20 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "11523-0082-1", "marketing_start_date": "20211220"}], "brand_name": "Lotrimin Ultra", "product_id": "11523-0082_4526ca36-993f-b574-e063-6294a90a8fba", "dosage_form": "CREAM", "pharm_class": ["Benzylamine Antifungal [EPC]", "Benzylamines [CS]"], "product_ndc": "11523-0082", "generic_name": "Butenafine hydrochloride", "labeler_name": "Bayer Healthcare LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Lotrimin Ultra", "active_ingredients": [{"name": "BUTENAFINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "NDA021307", "marketing_category": "NDA", "marketing_start_date": "20211220", "listing_expiration_date": "20261231"}